Kornimate/medical-research-clean huggingface dataset:
radiotherapy with humidification in head and neck cancer

Conditions: Cancer of the Head and Neck

Summary: this is a two arm randomised phase iii trial which will evaluate prospectively the benefits of humidification in patients receiving radiotherapy / chemoradiation for head and neck cancer. the intent of humidification is to moisturise the mucosa. the rationale for the use of humidification with radiotherapy can be considered an extension of the general principle of moist wound care in wound management.

this phase iii trial will address four hypotheses. the primary hypothesis is: humidification will modulate the natural history of mucositis resulting in a clinically significant reduction in the intensity of severe acute mucositis as a function of time for ctcae grade \> 1 mucositis (e.g. grade 2 or higher), measured as the area under the time curve (auc) of the plot expressing grade of acute reactions vs weeks for observed ctcae mucosal reactions \> 1 the additional hypotheses are: * humidification will palliate the acute symptoms of mucositis and xerostomia * humidification is cost effective through a reduction in hospital bed occupancy * humidification will improve the functional outcome, particularly swallowing function, of patients with head and neck cancer treated with radiotherapy

Eligibility criteria:
inclusion criteria: patients who meet the following criteria will be eligible: * pathologically confirmed diagnosis of cancer involving the nasopharynx, oropharynx, oral cavity, larynx, or hypopharynx * regional nodal irradiation included in ptv1 (as a minimum ipsilateral levels ii-iii) * prescribed dose of radiotherapy is at least 60 gy * receiving definitive or post-operative adjuvant radiotherapy * receiving radiotherapy as sole modality or chemoradiation * patient \> 18 years old * available for follow-up for up to 2 years * life expectancy greater than 6 months * written informed consent * participation of patients on other clinical trial protocols permitted exclusion criteria: patients who meet the following criteria will be excluded: * presence of tracheostomy or stoma * diagnosis of t1 / t2 glottic carcinoma * undergoing cpap therapy -treatment with amifostine or palifermin (keratinocyte growth factor) during radiotherapy * history of previous radiotherapy to the head and neck region, excluding superficial radiotherapy to cutaneous squamous cell carcinoma or basal cell carcinoma * high risk for poor compliance with radiotherapy, humidification, or follow-up as assessed by the investigator

Keywords: radiotherapy humidification mucositis
effects of chlorhexidine toothpaste on wound healing after impacted tooth extraction

Conditions: Tooth Impaction; Tooth Diseases

Summary: in this study, the postoperative clinical and microbiologic effects of chlorhexidine toothpaste and chlorhexidine-free toothpaste with the same content were compared after bilateral mandibular impacted third molar surgery. similarly positioned fully impacted impacted lower third molars were extracted. bilateral impacted wisdom teeth of the patients were randomly selected. after the operation, the experimental group received dentasave 0.2% chlorhexidine toothpaste containing chlorhexidine and the control group received toothpaste with the same content but without chlorhexidine. teeth were extracted by the same dentist at 14-day intervals. for microbiological analysis, saliva samples were taken before the first tooth extraction, before the second tooth extraction 14 days later and on the 28th day and sent to the microbiology laboratory. wound healing, edema and trismus in both extractions were evaluated 1 week after tooth extraction. wound healing was evaluated as good, acceptable and poor. vas (visual analog scale) was used for pain assessment and recorded 14 days after tooth extraction.


Eligibility criteria:
inclusion criteria: * volunteers with bilateral fully impacted mandibular wisdom teeth exclusion criteria: * patients were excluded from the study if they did not understand the clinical procedures of the study, * had allergies or intolerance to any of the substances used in the study, * patients on anticoagulant or psychiatric treatment, * pregnant or breastfeeding, * patients using oral contraceptiveswere, * diabetic, * patients with periodontal disease or active infection * smokers of more than 10 cigarettes per day, * poor oral hygiene

Keywords: chlorhexidine, wisdom teeth, dental surgery
intraoperative flow cytometry in colorectal cancer

Conditions: Colorectal Cancer

Summary: this study was designed to investigate the efficacy of flow cytometry to accurately identify between normal and cancer cells in colon epithelium in humans diagnosed with colorectal cancer.

tissue samples from normal and cancerous colon epithelium are collected intraoperatively following standard colectomy and analyzed blindly by flow cytometry, which reports, in less than 10 min, on the origin of the sample based in the estimation of dna and tumor index.

Eligibility criteria:
inclusion criteria: biopsy proven colorectal cancer signed informed consent for participation exclusion criteria:
topical tofacitinib for the treatment of alopecia areata and its variants

Conditions: Alopecia Areata; Alopecia Totalis; Alopecia Universalis

Summary: the purpose of the study is to investigate the use of topical tofacitinib to promote hair regrowth in patients with alopecia areata, alopecia totalis, and alopecia universalis.

this will be an open label clinical trial. we plan to treat 10 adults with aa (with at least 2 patches of alopecia involving the scalp), at or au with tofacitinib ointment for a maximum of 6 months. during treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth. laboratory evaluation will be performed before and during treatment in order to monitor for adverse effects of the medication.

Eligibility criteria:
inclusion criteria: * diagnosis of aa with at least 2 patches of alopecia involving the scalp, at or au * stable hair loss present for 6 months or longer * no treatment for alopecia areata in the past 1 month * no evidence of spontaneous hair regrowth exclusion criteria: * patients have received treatment known to affect alopecia areata within 1 month of enrolling in the study * patients whose current episode of at or au is more than 5 years * patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin) * patients known to be hiv or hepatitis b or c positive * patients with positive tuberculin skin test or positive quantiferon® tb test * patients with leukopenia or anemia * patients with renal or hepatic impairment * patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or tnf-α inhibitors * women who are pregnant or nursing

Keywords: alopecia
precise treatment of ceftazidime-avibactam in patients with cro infections under the guidance of tdm and ppk model

Conditions: ECMO; Carbapenem-Resistant Enterobacteriaceae Infection

Summary: the goal of this study is to evaluate the efficacy and safety of ceftazidime-avibactam(caz-avi) in the treatment of critically ill patients with carbapenem-resistant organisms(cro) infections (including dialysis patients and extracorporeal membrane oxygenation(ecmo) patients).

this is a prospective observational multicentre study. the study is to obtain the real world data of the efficacy and safety of ceftazidime-avibactam(caz-avi) in the treatment of critically ill patients with carbapenem-resistant organisms(cro) infections (including dialysis patients and extracorporeal membrane oxygenation(ecmo) patients) by using therapeutic drug monitoring(tdm). a population-pharmacokinetic(ppk) model of caz-av in these patients will be established in this study. the main question it aims to answer is the clinical success rate and microbiological success rate of caz-avi based regimen in the treatment of critically ill patients with cro infections. according to the clinical practice (symptoms, signs, imaging, culture and drug sensitivity, etc.), the doctor determines the combined regimen of caz-avi, and the combined drugs are used routinely according to their instructions or clinical diagnosis and treatment.

Eligibility criteria:
inclusion criteria: 1. 18-85 years old. 2. hospitalized participants in icu who did not receive ceftazidime avibactam treatment within 15 days before joining the study. 3. participants with severe infection (refer to the 2022 sepsis3.0 guidelines for the definition of severe infection). 4. at least one carbapenem-resistant gram-negative pathogen (including but not limited to carbapenem-resistant enterobacteriaceae and / or pseudomonas aeruginosa) was confirmed by bacterial culture in the primary infection site samples. 5. sufficient respiratory secretions, blood and peritoneal effusion can be obtained within 48 hours before the first administration for bacterial culture and drug sensitivity test. 6. intravenous injection of ceftazidime avibactam for more than 72 hours. 7. understand compliance with research procedures and methods, voluntarily participate in this study, and sign informed consent in writing. exclusion criteria: 1. participants are less than 18. 2. death within 72 hours after the start of treatment. 3. known resistance to β-lactam antibacterial drugs including cephalosporins, cephalosporin compound preparations containing β-lactamase inhibitors, or those with a history of allergies to ceftazidime avibactam sodium for injection and its excipients. 4. no indication for treatment with ceftazidime avibactam. 5. pregnant and lactating women.
gluteus maximus transfer following tha does not improve abductor strength

Conditions: Hip Arthropathy

Summary: gluteus maximus transfer following tha does not improve abductor strength - a case-control gait analysis study of 15 patients with gluteus medius disruption the investigators have compared 15 gluteus maximus transferred patients with the use of a gait analysis system based on reflective markers and force plates to objectively evaluate the gait performance pre- and postoperatively.

the gluteus maximus flap transfer (gmt) is a surgical technique to improve gait kinematics and kinetics as well as reduce pain and ameliorate functional outcome in patients with hip abductor deficiency of the gluteus medius following total hip arthroplasty (tha). the investigators used a gait analysis system based on reflective markers and force plates to objectively evaluate gait performance pre- and postoperatively. methods gait analysis was performed in 15 patients who underwent gmt and were examined with an optical tracking system before and at a minimum of 13 months after the operation. mean age was 69 years (sd=11), all were females. median follow-up time was 24 (13-60) months. the primary outcome was hip abduction moment (nm/kg) during gait. the control group consisted of 66 subjects without any gait pathology.

Eligibility criteria:
inclusion criteria: * patients with hip abductor deficiency of the gluteus medius following total hip arthroplasty (tha) exclusion criteria: * tha prior to the muscle transfer
deafness and cognition in middle-aged adults

Conditions: Mild Cognitive Impairment in Middle-aged Adults

Summary: a mild cognitive impairment was observed in 50% of cochlear implant candidates aged 65 years and over, compared to 5-19% in general population. no studies analysed cognition in patients younger than 65 years. the aim of our study was to compare cognitive function between patients with severe and profound hearing loss and patients with normal hearing in patients aged 45 to 64 years.

this case-control study will include 180 middle aged adults (90 cases, 90 healthy controls) matched on sex, age, education level in order to find an association between severe and profound hearing loss and presence of mild cognitive impairment. 90 subjects with severe to profound hearing loss,, with a maximum speech intelligibility of 70% for fournier's disyllabic words in silence with properly fitted hearing aids could be included. cognition evaluated on a battery of 5 tests, depression and dependance will be compared to healthy controls with normal hearing on pure-tone audiometry (as function of iso 7029 reference) the subjects (cases and controls) will be recruited in the ent consultation from the cochlear implant center (unité fonctionnelle implants auditifs, pitié-salpêtrière hospital, head: dr isabelle mosnier)

Eligibility criteria:
inclusion criteria: * cases: patients aged between 45 to 64 years with severe to profound bilateral post-lingual sensorineural hearing loss with a maximum intelligibility of 70% (disyllabic words) in free-field silence with hearing aids at 60 db spl, current in french * controls: normal hearing subjects matched on age, sex and education level exclusion criteria: * associated disability that prevents the tests from being performed * past and current history of neurological and psychiatric disorders including meningitis * psychotropic drug treatment * vulnerable subject

Keywords: severe and profound hearing loss mild cognitive impairment (mci) middle aged adult depression
a trial evaluating the effect of nn1250 at steady state conditions in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial was conducted in europe. the aim of this clinical trial was to evaluate the effect on the blood glucose-lowering effect of nn1250 (insulin degludec) in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * current total daily insulin treatment lower than 1.2 (i)u/kg/day * body mass index 18.0-28.0 kg/m\^2 exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period * supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmhg for systolic or 50-90 mmhg for diastolic
korean post-marketing surveillance for kombiglyze xr®

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of kombiglyze extended release (xr) so that the regulatory authority can manage the marketing approval properly


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * ≥ 18 years of age * have diagnosed type 2 diabetes mellitus (t2dm) * are initiating kombiglyze xr treatment within the approved korean indications exclusion criteria: * being treated for an indication not approved for the use of kombiglyze xr in korea * is contraindicated for the use of kombiglyze xr as described in the korean label
autologous car t-cells targeting the gd2 antigen for lung cancer

Conditions: Lung Cancer; Small Cell Lung Carcinoma; Non Small Cell Lung Cancer

Summary: this is a phase 1, single-center, open-label study that enrolls adult subjects with extensive stage lung cancer or stage iv non-small cell lung cancer that is platinum-refractory and received pd-1 and/or pd-l1 therapy. the purpose of this study is to test the safety of using a new treatment called autologous t lymphocyte chimeric antigen receptor cells against the gd2 antigen (ic9-gd2.car.il-15 t cells) in subjects with lung cancer. how much (dose) of the ic9-gd2.car.il-15 t cells are safe to use without causing too many side effects and what is the maximum dose that could be tolerated will be studied. modified immune cells as an experimental treatment that combines antibodies and t cells will be used. antibodies are proteins that protect the body from foreign invaders like bacteria. t cells, also called t lymphocytes, are special infection-fighting blood cells that can kill viruses and other cells, including tumor cells. although antibodies and t cells have been used to treat cancer and they both have shown promise, neither alone has been able to cure most patients. this study will combine t cells and antibodies to create a more effective treatment. the treatment that is being researched in this study is called autologous t lymphocyte chimeric antigen receptor cells targeted against the disialoganglioside (gd2) antigen that expresses interleukin (il)-15, and the inducible caspase 9 safety switch (ic9). the short name for this treatment is ic9.gd2.car.il-15 t cells therapy is an experimental therapy and has not been approved by the food and drug administration. there are two steps. in the first step, blood will be collected from the subjects to prepare the ic9-gd2.car.il-15 t cells. t cells will be isolated from the blood and modified to make ic9-gd2.car.il-15. in the second step, the ic9-gd2.car.il-15 t cells produced from the subject's own blood will be administered to the subject.


Eligibility criteria:
inclusion criteria: 1. written informed consent to undergo cell procurement explained to, understood by, and signed by the subject. 2. subject has a life expectancy of ≥ 12 weeks. 3. subject must be platinum-refractory and either currently receiving or has previously received a pd1/pdl1 inhibitor 4. use of systemic corticosteroids at doses ≥10 mg prednisone daily or it's equivalent; those receiving \<10 mg daily may be enrolled at the discretion of the investigator. 5. female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to cell procurement. 6. subject has demonstrated adequate organ function. exclusion criteria: 1 . subject has less than 12 weeks of life expectancy. 2. subject did not receive platinum-based chemotherapy 3. subject does not have adequate organ function.

Keywords: cellular therapy
colchicine and inflammation in aortic stenosis

Conditions: Aortic Valve Disease; Aortic Valve Stenosis; Aortic Valve Calcification; Inflammation; Calcification; Cardiovascular Diseases

Summary: aortic stenosis (as) is the most common valvular heart disease in the developed world. once symptomatic, untreated patients have a poor prognosis with five-year survival rate of 25%. once at an advanced stage, as will lead to the development of left ventricle hypertrophy, and eventually heart failure and death. at-present, there is no effective medical therapy for aortic stenosis. current management of patients with as consists of 'watchful waiting'. valve replacement is needed when these patients (often acutely) become symptomatic. recent studies have shown that inflammatory processes with similarities to atherosclerosis play an important role in as. therefore, we hypothesize that treatment with anti-inflammatory therapy, in the form of colchicine, could reduce the progression of as. if positive, this trial will be the first to provide a potential therapeutic option for millions of people world-wide with as.


Eligibility criteria:
inclusion criterion: • asymptomatic moderate aortic valve stenosis on recent (\<6 months) echocardiography (based on peak velocity, mean gradient, aortic valve area). the severity of as will be quantified according to current eacvi / ase guidelines. exclusion criteria: * heavily calcified aortic valve on echocardiography (defined as grade 4 calcification: extensive thickening/calcification of all cusps as described in the articles by rosenhek et al.); * a planned aortic valve replacement in the next six months; * severe mitral valve stenosis (mva \< 1cm2); * severe mitral or aortic valve regurgitation; * rheumatic aortic valve disease; * bicuspid aortic valve; * valvular disease due to history of chest radiation; * left ventricular dysfunction (lvef \< 35%); * renal impairment (egfr \<30 ml/min/1.73m2); * patients aged \ 80 years; * pre-existing chronic gastro-intestinal complaints which may obscure signs of colchicine intolerance; * child-bearing potential without the use of contraception; * use of cyp3a4 (e.g. verapamil) or p-glycoprotein inhibitors; * use of bisphosphonate or denosumab; * chronic use of immunosuppressants or anti-inflammatory drugs including colchicine and nsaid's (excl. acetylsalicylic acid); * active or chronic liver disease; * the presence of a pacemaker or internal cardiac defibrillator; * life expectancy \<2 years.

Keywords: aortic stenosis inflammation
comparison of expression of carcinogenesis-related molecular markers in the patients with colon cancer and polyp

Conditions: Colorectal Cancer; Colorectal Adenoma

Summary: a study of carcinogenesis-related molecular markers in the patients with colorectal cancer and colorectal adenoma.

the chromosomal instability (cin) pathway, the cpg island methylator phenotype (cimp) pathway and the microsatellite instability (msi) pathway are three major carcinogenesis pathways to colorectal cancer (crc). in this study, the investigators aimed to investigate distinctive molecular features of carcinogenesis pathways among healthy control, colorectal adenoma, and crc and compare their molecular progression according to patients' sex and tumor location as well as disease stage.

Eligibility criteria:
inclusion criteria: * control group: subjects with no evidence of colorectal adenoma or colorectal cancer * colorectal adenoma group: patients with colorectal adenomas greater than or equal to 10 mm in diameter according to the endoscopic presentation as well as histological validation of colorectal adenoma. * colorectal cancer group: patients whose biopsy specimen is histologically confirmed as colorectal adenocarcinoma exclusion criteria: * subjects age under 18 years * previous history of colorectal neoplasms * patients with high bleeding risk or patients who must maintain anti-coagulant or anti-platelet agents * denial to participate in this study

Keywords: carcinogenesis sex difference tumor location